“Transparency Advocates Win Victory for Public Access to Clinical Trial Data” was a headline that made a splash in the transparency and disclosure space last week. A federal judge ordered to expand the public’s right to access results of clinical trials studying drugs and medical devices. The judge ruled that the Food and Drug Administration (FDA), National Institutes of Health (NIH), and Department of Health and Human Services (HHS) have misinterpreted a 2007 law that requires drug companies, universities, and other sponsors of clinical trials to publicly disclose the results of FDA-approved products via the ClinicalTrials.gov website. This would involve about a decade’s worth of trial results, making data from potentially hundreds of clinical trials available for the first time. This response is allegedly due to a loophole that exempted many clinical trials completed between 2007 and 2017 where no results were reported.
In order to understand the full impact of this ruling, we reached out to the Transparency and Disclosure experts at ClaritiDox, LLC and d-wise to ask them a few questions.
Q: Can you explain more about what types of clinical trials were classified as “loophole” trials and did not report results?
A: In short, a “loophole” trial was considered an applicable clinical trial (ACT) under FDAA, but not under the Final Rule, which came ten years later. If the trial completed before the Final Rule went into effect, and if the trial studied a product that was not FDA-approved prior to the study’s primary completion date, it no longer required results disclosure. In order to understand how the loophole was created, you need a little background and some general familiarity with disclosure lingo.
FADAMA (1997) and then FDAAA (2007) outlined regulations for registering study protocols and disclosing results of these trials on ClinicalTrials.gov. Next, the Final Rule (42 CRF Part 11), clarified and expanded clinical trial registration and results requirements and further defined which studies were considered “applicable” under the previous regulations as well. The Final Rule was effective January 18, 2017. Importantly, the Final Rule stated (or was interpreted to state) that for any study that completed before the Final Rule went into effect, the regulations only applied if the product studied in that trial was approved by the FDA (for any indication) before the study’s primary completion date. It limited the disclosure requirement to only trials that studied an approved product and whose approval date was prior to the primary completion date. Any trial that completed before the Final Rule, with a product unapproved prior to its primary completion date, essentially could come off the Sponsor’s results to-do list.
Q: If this ruling stands, what do you think the resourcing impact will be on the Sponsors of these clinical trials?
A: Sponsors and researchers who initiated their disclosure programs in earnest after the Final Rule or those who have been doing the minimum since 2017 (or in some cases, have done no disclosures at all yet) will have some additional catching up to do. Anyone who eliminated these “loophole trials” from their to-do list will need to integrate them back into scope. If they don’t have the internal expertise and resources who can absorb this, they will likely require assistance from external partners. It’s hard enough for most groups to keep up and reach a steady-state of compliance; when you add catching up on top of that, it will be challenging.
Q: The judge also said that it could not grant relief on a separate claim, which asked for an order requiring NIH to post public notices of noncompliance when Sponsors do not submit their clinical trial results. Can you give an overview of the different ways the public can see if a Sponsor has not been compliant with results disclosure?
A: There are different organizations and websites that track Sponsor’s compliance with results disclosure, which are helpful, informative tools. Of note, there may be studies that look like they are out of compliance with posting the results to the public but there may also be restrictions or circumstances at play behind the scenes that make it difficult to see the whole story of why a study is noncompliant. Most people we encounter in the disclosure space—people we know after working on disclosure with Sponsors of all sizes for years and from attending conferences devoted to disclosure compliance—are trying hard to proactively make data available to the public in a thoughtful and responsible manner. Sponsors who work in the rare disease space, for example, have a unique challenge in that sharing their data is critically important to their community, but they also can’t risk patient identification. Some examples the public can use to see various Sponsors’ compliance with results disclosure include: https://bioethicsinternational.org/good-pharma-scorecard/, http://fdaaa.trialstracker.net/, https://eu.trialstracker.net/,
For more information on the original article and links to the lawsuit, please visit https://cspinet.org/news/transparency-advocates-win-victory-public-access-clinical-trial-data-20200225
Special thanks to Kimmy Green, Brenda Tiffin, and Courtneay Parsons from ClaritiDox, LLC. for their contribution to this blog post.
